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Power the BenchAn Enhanced Strategy for Data Integrity

Acquire workflow control, traceability and data automation with laboratory bench top instruments and balances fully integrated in the Lab environment.

Contents Page1 The intention and reality 2

2 The challenge 2

3 Power the Bench, a better approach 2

4 Summary 6

2 White Paper METTLER TOLEDO

Pow

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One of the primary motives driving organizations to purchase a LIMS, ELN, or LES [collectively, Laboratory Informat-ics Systems (LIS)] is the appeal of connecting laboratory instruments to them for electronic data collection. When a laboratory instrument is directly connected for electronic data capture, the costs in time, labor, and potential error associated with manual transfer of data are essentially eliminated. However, even with the compelling advantages, many instruments and systems still remain disassociated and data entry and transfer largely handled manually. Manual data transcription and report creation keep the laboratory analyst from focusing on the science. Frequently, the transcribed data is missing elements and the traceability needed to satisfy internal quality management and regulatory mandates. The end result is that time and revenue are lost due to the time and effort it takes laboratory analysts to resolve the situation by gathering missing data, re-transcribing results, documenting missing controls, and preparing reports.

2 The Challenge

The laboratory analyst must often comply with standard operating procedures (SOP) for each analysis and doc-ument the entire process as well as record the results. While many labs have turned toward LIMS and ELN sys-tems with the idea of replacing the manual workflow, these systems are designed primarily to aggregate result data from an array of analytical tests - not automate and document bench top workflows or bind instrument meta-data to the measurement. As many organizations have discovered, workflows behind bench top analyti-cal instruments (such as balances, titrators, pH meters, and similar instruments), and the associated results, instrument information, user information, and method used, etc. (metadata) are much more complex than just the transfer of a few parameters. Complicating matters further, regulatory and standards such as FDA (21 CFR Part 11), EU (Annex 11), GMP, and ISO (ISO 17025) have recognized both the advantages and limits of electronic data systems, and have increasingly established further controls for the use of such systems all the way down to bench top instruments. So the goal of reducing errors, simplifying processes, and reinforcing compliance can become further challenging when trying to directly integrate and automate the lab bench top.

Taking the example of a weighing 'loss on drying' applica-tion where multiple, sequenced weighing, calculations, and sample tracking must be accomplished, capturing only lim-ited measurement data electronically without the full meta-data set (instrument, user, tare vessels, sample qualitative data, calibration history, SOP, method version, etc.) leaves the measurement without context and misses the objective. It is soon discovered that the process cannot be effectively managed without some degree of workflow interaction with the balance itself.

3 Power the Bench – A Better Approach

What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument, and that delivers automatic, integrated instrument management and data capture functionality to improve productivity and efficiency by centering the work on the instrument. With the expertise gained as a sin-gle-brand provider of the most frequently-used laboratory bench top instruments, METTLER TOLEDO introduced LabX software to deliver a single-vendor platform solution to the bench top integration challenge.

3White Paper METTLER TOLEDO

As shown in Fig. 1, use of LabX instrument control and workflow software forms the foundation of the IT hierarchy and creates a fully self-contained system with the balances and instruments at the bench top layer. Centrally maintained SOP's are driven by LabX to the respective instrument to guide measurement and data capture and to store all raw and processed measurement data with corresponding metadata sets for further use. The bench top layer in turn can interact on a unidirectional or bi-directional basis with the other layers in the IT hierarchy using standardized integration approaches. With LabX, laboratories have a practi-cal, cost-effective, automated solution for managing instruments and measurement data together in a single system that can be integrated further with the lab's core scientific systems such as ELN or LIMS. The LabX software system works uniquely with the instrument firmware, helping it to remain the center of the experi-ence for the user working at the bench. Fig.1 Workflow and Instrument control software

LabX Bench top Instrument Layer

In a LabX system, no computer or tablet PC is needed on or near the bench top. Driven from LabX, the balance or instrument touch screen delivers real-time, step-by-step workflow guidance to the user according to the lab's own SOP's. SOP's are easily configured with the flexible workflow tool that takes advantage of the balance and instru-ment-specific features uniquely present in each model's firmware. When ready to begin work, the analyst simply touches a shortcut or selects a desired workflow from a selection on the balance or instrument. When complete, data can be analyzed in LabX on a networked PC in the lab or office, reports generated, and data sent to the LIS as .csv, .xml or via a web services API.

In comparison with manual transcription of data, a variety of possibilities exist for integration which bring with them various degrees of data transfer capability, regulation support, and user guidance.

LabX(LIS) Lab systems direct to instrument

Drop transfer

.pdf trans-fer

Peripheral communi-cation

Auto import/export

API web services

Full bi-directional data transfer √

Control complete process from LIS or instrument

√

Connect LIS ID to sample data √ √

Interface with data systems and inventory

√ √ √

Meta data (important sample and instrument data)

√ √ √ √

Integrate to any system √ √ √ √

User Management √ √ √ √ √

Updated firmware and instruments supported

√ √ √ √ √

Traceability √ √ √ √ √

SOP guidance √ √ √ √ √

Instrument control √ √ √ √ √

Support regulation compliance √ √ √ √ √ √

Improve efficiency √ √ √ √ √ √

Remove transaction errors √ √ √ √ √ √

4 White Paper METTLER TOLEDO

Pow

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nch Definitions of the typical ways of transferring data of integrated systems:

Manual data transfer Work on the instrument according to SOP written on paper. Make calcula-tions manually, write results in a lab notebook, and enter the values back on the instrument manually. Write results in lab notebook. Manually enter the results and information into the LIS. Store the lab notebooks on shelf for future audit usage.

(LIS) Lab Information Systems direct to instrument

Lab Information System vendor or integration company programs custom code to each driver of each instrument. Result value available typically when pressing print on instrument. Changes to instruments or updates to firmware or software often require reprogramming of custom code and revalidation efforts.

Drop transfer Using the 'Transfer Data' method function within a method; during the workflow data is transferred into an open cursor position in excel. Data can be sent to excel; all meta data is available (e.g. instrument informa-tion, user information, results...).

.pdf transfer As flexible and detailed as a report printed on a network printer, a .pdf report is created and stored in a folder on the network. Many LIS systems have the capability to read this .pdf data, import the files and input in to their system.

Peripheral communication Send and receive data from external systems during the workflow. Two way communication between instruments.

Auto import/export Export: Extensive meta data for results, products, and sample series can be exported as a .csv or XML formatted file. This file can be configured in various ways (e.g. after electronic signature, only if results are with toler-ance range, or simply automatically to any folder from which any other information system can import the file).Import: From most information systems send files in .csv or XML format for tasks, products, and sample series. LabX either manually or automatically runs or imports files as defined and required."

API webservices integration Using the common web services techniques, an extensive amount of data can be exchanged between LabX and other software systems, instruments, even mobile devices. Information, running methods and tasks, getting reports and complete data can be triggered by various external software systems or instruments at various points within the workflow. This is a true bi-directional communication and connects the systems together as close as possible as one system. In practice users can create and start tasks from either the LIS system or directly on the instrument touchscreen. All data flows back and forth through this expanded network of the system at multiple points as required by the Lab's working style.

LabX

5White Paper METTLER TOLEDO

The path of the data can be considered a one-way or a two-way street. Depend-ing on the needed data and desired level of integration, the following paths could be followed:

Standard LabX using "transfer data" method

function

Standard LabX automatically

saves .pdf report

System Inte- gration option

(API web services)

Automatic import/export option

Only need results sent to LIS systemMore than just results. Need to send and receive data to

and from LIS

Excel accepts data sent to

selected field in open worksheet

LIS can import .pdf data

LIS can pick up .csv/XML file to

use in LIS

Send results to file in .csv or XML

Import from file location / export

to folder

Send product data and sample series data from LIS to the instrument,

and receive data back to LIS

Instrument and task control from

the LIS / send instru-ment and

result data to LIS

TWOWAY

Mettler-Toledo AG, AnalyticalCH-8603 SchwerzenbachTel.: +41 44 806 71 11Fax +41 44 806 72 40

Subject to technical changes©01/2015 Mettler-Toledo AGGlobal MarCom Switzerland

4 Summary

Directly connecting laboratory balances and instruments to LIS systems offers significant advantages but imple-mentation can suffer from technical limitations and cost overruns with less than desirable results. Using LabX instrument control software which incorporates the lab bench top balances and instruments to form a single "bench top environment" at the IT foundation level offers significant advantages and efficiencies compared to other approaches.Integrating LabX instrument control software with other Lab Informatics Systems using .csv files, XML structure or the API web services closes the gap in traceability, simplicity, total cost of ownership (TCO), and cost/time efficiency. Any system that can handle .csv, .xml or web services can integrate directly with LabX and in turn, its connected instruments.

? Question: "Can my LIMS system connect to LabX?" Answer: "Any system that can handle .csv, .xml or API web services can integrate directly with LabX and in turn, its connected instruments."

For lab systems, multiple bench top instruments now have a single integration point engineered and maintained by the same manufacturer of the instruments and software. The lab can benefit from the best of breed approach. That is, bench top instruments, instrument control software, and LIS, each doing what they are designed to do best, and working together to obtain the full advantages of each with minimal overhead.

By installing LabX software organizations wishing to improve weighing and analytical results, quality compli-ance, and efficiency through automation can take advantage of the instrument technology which in many cases, already resides on the bench top. Together, the system offers an easy-to-use, transparent user experience that uniquely addresses many challenges of the user organization. METTLER TOLEDO provides full support services for easy start-up and can assist with guidance on establishing and maintaining effective quality management programs to compliment a LabX installation.

www.mt.comFor more information